December 7, 2016

Real-World Evidence — What Is It and What Can It Tell Us?

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Abstract

The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records, billing databases, and product and disease registries — to assess the safety and effectiveness of drugs and devices.

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Authors

Rachel E. Sherman

Steven A. Anderson

Gerald J. Dal Pan

Journals

New England Journal of Medicine

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Institutions

United States Food and Drug Administration

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

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Real-World Evidence — What Is It and What Can It Tell Us?

Key Points

Abstract

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Discussion

Authors

Journals

Actions

Institutions

References and Citations

Citation Network

Connected Papers

Discussion

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